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Re: greenehugh post# 6108

Saturday, 12/25/2004 6:49:19 PM

Saturday, December 25, 2004 6:49:19 PM

Post# of 257644
This was found in the 8-K on 12/21/04. No press release on it. Dr. Garren thinks it is very significant. Any comments?

SNUS

In September 2004, Sonus Pharmaceuticals requested and was subsequently granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss its plans for Phase 3 testing of TOCOSOLÒ Paclitaxel, the Company's lead cancer product. Sonus met with the FDA in December 2004, and based on preclinical and clinical data generated to date, the Agency has indicated that it is appropriate for Sonus to pursue Phase 3 testing and submission of a TOCOSOL Paclitaxel New Drug Application under a 505(b)(2) regulatory mechanism. In addition, the FDA has recommended that Sonus finalize the design and plan of the TOCOSOL Paclitaxel Phase 3 program under a Special Protocol Assessment, which the Company plans to pursue. As previously disclosed, Sonus expects to initiate Phase 3 testing of TOCOSOL Paclitaxel in the second quarter of 2005.


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